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Subacromial Pain Syndrome. Treatment, Diagnostic Imaging and Predictors of Outcome

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Subacromial Pain Syndrome. Treatment, Diagnostic Imaging and Predictors of Outcome Subacromial Pain Syndrome. Treatment, diagnostic imaging and predictors of outcome. PhD Thesis Elisabeth Kvalvaag Faculty of Medicine, University of Oslo Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Ullevaal November 2017 © Elisabeth Kvalvaag, 2018 Series of dissertations submitted to the Faculty of Medicine, University of Oslo ISBN 978-82-8377-209-8 All rights reserved. No part of this publication may be reproduced or transmitted, in any form or by any means, without permission. Cover: Hanne Baadsgaard Utigard. Print production: Reprosentralen, University of Oslo. CONTENTS 1. Acknowledgements 2. List of papers 3. Abbreviations 4. Summary 5. Introduction 5.1 Epidemiology of shoulder pain 5.2 Anatomy of the shoulder 5.3 Painful conditions of the shoulder 5.4 Subacromial pain syndrome 5.4.1 Pathogenesis 5.4.2 Symptoms and clinical findings 5.4.3 Diagnostic imaging of the shoulder 5.4.4 Therapy strategies 5.4.5 Prognostic factors 5.5 Placebo 6. Aims of the research 7. Methods 7.1 Study design 7.2 Patients 7.3 Randomization and blinding 7.4 Patient assessment 7.5 Outcomes 7.6 Interventions 7.7 Statistics and sample size 7.7.1 Power estimation 7.7.2 Comparing groups 7.7.3 Associations 8. Summary of papers 8.1 Paper I 8.2 Paper II 8.3 Paper III 8.4 Paper IV 9. Discussion 9.1 Patient sample and external validity 1 9.2 Patient sample and internal validity 9.3 Study Design 9.4 Sample size and statistics 9.5 Results in relation to existing knowledge 9.5.1 Efficacy of rESWT versus sham rESWT in addition to supervised exercises 9.5.2 Predictors of SPADI and return to work after one year 9.5.3 MRI of the shoulder 9.6 Clinical implications 10. Conclusions 11. Future research 2 1. Acknowledgements This work has been carried out during the years 2011-2017, while I was employed as a research fellow at the University of Oslo and Department of Physical Medicine and Rehabilitation at Oslo University Hospital, Ullevål. All of these years have been very exciting, educational, and from time to time challenging. But I have been so lucky to work with a large group of people that have helped me during the process, and I am deeply grateful to all of you. I especially want to thank my main supervisor Professor Cecilie Røe, Head of the Department of Physical Medicine and Rehabilitation. She hired me and believed in me from the beginning, even though my research experience was very limited. During the whole process, she has always been available for me and patient with me, and she has provided the perfect setting for undertaking such a project. Her extensive experience, unlimited capacity, competent advice and encouraging support have been invaluable for me. I am also extremely thankful to Professor Jens Ivar Brox, my second supervisor. His everlasting interest and patience, and vast experience in medical research in general, and shoulder research in particular, have been crucial for the completion of this work. Thank you so much for your enthusiastic, quick and constructive feedback on my innumerable questions! Special thanks go to Dr. Helene Søberg, my third supervisor, for her constructive feedback and support during the whole process. I am also grateful to Dr. Kaia Beck Engebretsen, for good advice and educational discussions, and for treating some of the patients in the study with supervised exercises. I would also like to thank Dr. Niels Gunnar Juel, for his patience, keen interest and skilful advice. His experience and outstanding knowledge regarding shoulder patients have been invaluable in my years at the shoulder clinic, and in my development as a clinician. 3 Many thanks go to Professor Leiv Sandvik, for interesting discussions and important advice concerning the statistical methods performed. I also want to thank Professor Erik Bautz-Holter, the project manager of this project, for always providing friendly help and constructive feedback. All my colleagues at the Department of Physical Medicine and Rehabilitation at OUH also deserve my gratefulness for their contribution and help in recruiting patients, and for creating such a good working atmosphere. Special thanks to Kathrine Hope and Danijela Miletic for practical assistance, and the physiotherapists who performed the treatments at OUH. Special thanks to all the study patients for their time and willingness to participate in this study, and to Egill Knag in Enimed for technical support. I would also like to thank Sophies Minde Ortopedi AS for funding of the project. Finally, I would like to thank my family for the most important support. My husband and best friend, Stian, for his interest in the project, encouragment and support. And our three children, Stella, Mikkel and Frida, the very best in my life. Oslo, October 2017 Elisabeth Kvalvaag 4 2. List of papers 1. Kvalvaag E, Brox JI, Engebretsen KB, Søberg HL, Bautz-Holter E, Røe, C. Is radial Extracorporeal Shock Wave Therapy (rESWT) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind, randomised, sham-controlled trial. BMC Musculoskelet Disord. 2015; 16(1):248 2. Kvalvaag E, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C. Effectiveness of Radial Extracorporeal Shock Wave Therapy (rESWT) when combined with Supervised Exercises in Patients With Subacromial Shoulder Pain: A Double-Masked, Randomized, Sham-Controlled Trial. Am J Sports Med. 2017. Jun 1:363546517707505 3. Kvalvaag E, Røe C, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Brox JI. One year results of a randomized controlled trial on radial Extracorporeal Shock Wave Therapy with predictors of pain, disability and retun to work in patients with subacromial pain syndrome. Eur J Phys Rehabil Med 2017 Jun 27. DOI: 10.23736/S1973-9087.17.04748-7 4. Kvalvaag E, Anvar M, Karlberg AC, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C. Shoulder MRI features with clinical correlations in subacromial pain syndrome: A cross-sectional and prognostic study. BMC Musculoskelet Disord. 2017; 18(1):469 5 3. Abbreviations ADL Activities of Daily Living AROM Active range of motion ASD Arthroscopic Subacromial Decompression CI Confidence Interval fESWT Focused Extracorporeal Shock-Wave Therapy GP General practicioner ITT Intention To Treat MRI Magnetic Resonance Imaging OSD Open Subacromial Decompression PROM Passive range of motion RCRSP Rotator Cuff Related Shoulder Pain RCT Randomized clinical trial rESWT Radial Extracorporeal Shock-Wave Therapy SD Standard Deviation SAPS Subacromial Pain Syndrome SPADI Shoulder Pain and Disability Index VAS Visual analogue scale US Ultrasound 6 4. Summary Subacromial Pain Syndrome. Treatment, diagnostic imaging and predictors of outcome Elisabeth Kvalvaag, Oslo University Hospital, Ullevaal, Department of Physical Medicine and Rehabilitation and University of Oslo, Medical Faculty. Background: Shoulder pain is reported in almost half of the adult population yearly, and subacromial pain syndrome is diagnosed in about half the patients consulting. Non- surgical treatment including injection and exercises is the first choice. Radial Extracorporeal Shock Wave Therapy (rESWT) is another modality that is commonly used to treat this condition, but there is limited evidence for its effectiveness. Aims: 1) To compare improvement in pain and disability after radial Extracorporeal Shock Wave Therapy (rESWT) versus sham rESWT in patients who also received supervised exercises (paper I, II and III), 2) To explore how calcification of the rotator cuff and treatment beliefs influence the outcome (paper II and III), 3) To examine prognostic factors of one-year outcome (paper III), 4) To evaluate the association between structural changes detected on MRI and pain and disability (paper IV). Study Design: The main study is a randomized, controlled trial comparing supervised exercises and rESWT to supervised exercises and sham rESWT (paper I, II and III). Paper III is also a prognostic study that evaluates predictors of the Shoulder Pain and Disability Index (SPADI) and work status after one year. Paper IV is a cross-sectional and prospective observational study for identifying and evaluating imaging findings associated with SPADI baseline and the change in SPADI from baseline to one year follow up. Patients and method: One-hundred and forty-three patients between 25 and 70 years with subacromial pain syndrome lasting at least three months were randomly allocated to one of the two treatment groups (paper I, II and III). Of these patients, 115 had a recent MRI of their painful shoulder (paper IV). The rESWT and sham were performed once a week for the first four weeks, with the highest energy the patient could tolerate. Supervised exercises were performed once per week for the first four weeks, then twice per week for the next eight weeks. The principal focus of the supervised exercises was to unload stress on the subacromial structures by relearning normal movement patterns, with focus on posture and use of manual techniques for tense muscles. Later, endurance exercises with gradually increasing resistance were performed. Follow up was at 12 and 24 weeks (paper II) and one year (paper III and IV). The primary outcome was the Shoulder Pain and Disability Index (SPADI). Secondary outcome measures were pain at rest and daily activity and shoulder function the last week, health-related quality of life and return to work. Mixed model analysis (paper II) and linear regression analysis (paper III) were used for comparing the two treatment groups. Simple and multiple regression analyses were used for the evaluation of associations in paper III and IV. Results: At 24 weeks and one year, participants in both the sham group and the rESWT group had improved significantly in SPADI score compared with baseline, but there was no difference between the groups, except for the subgroup of patients with calcification in rotator cuff at 24 weeks.
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